Case Study / Scenario

Overview

Register several Establishments, with roles of Manufacturer, Importer, Relabeler. At least one company has a US Agent.

Elements of Scenario

• Relabeler
• Manufacturer
• Importer
• US Address
• Non-US Address
• US Agent

XML for this type of Registration/Listing

<?xml version="1.0" encoding="UTF-8"?>
<?xml-stylesheet href="http://www.accessdata.fda.gov/spl/stylesheet/spl.xsl" type="text/xsl"?>
<document xmlns="urn:hl7-org:v3" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:schemaLocation="urn:hl7-org:v3 http://www.accessdata.fda.gov/spl/schema/spl.xsd">
<id root="78b1e432-bce8-4733-9dc0-02f3742602c9"/>
<code code="51725-0" codeSystem="2.16.840.1.113883.6.1" displayName="ESTABLISHMENT REGISTRATION"/>
<title/>
<effectiveTime value="20080818"/>
<setId root="a9eaeb6c-effd-46e7-872c-0254c263fde9"/>
<versionNumber value="1"/>
<author>
<time/>
<assignedEntity>
<representedOrganization>
<assignedEntity>
<assignedOrganization>
<id extension="884918947" root="1.3.6.1.4.1.519.1"/>
<name>Reed Technology and Information Services Inc.</name>
<contactParty>
<addr>
<streetAddressLine>7 Walnut Grove Drive</streetAddressLine>
<city>Horsham</city>
<state>PA</state>
<postalCode>19044</postalCode>
<country>USA</country>
</addr>
<telecom value="tel:+1-215-734-2121"/>
<telecom value="mailto:gmin@reedtech.com"/>
<contactPerson>
<name>Grace Min</name>
</contactPerson>
</contactParty>
<assignedEntity>
<assignedOrganization>
<id extension="123456789" root="1.3.6.1.4.1.519.1"/>
<id extension="1234567" root="2.16.840.1.113883.4.82"/>
<name>RTIS Pharmaceuticals</name>
<addr>
<streetAddressLine>123 Jackson Avenue</streetAddressLine>
<city>London</city>
<state/>
<postalCode/>
<country>GBR</country>
</addr>
<contactParty>
<addr>
<streetAddressLine>100 Jackson Avenue</streetAddressLine>
<city>London</city>
<state/>
<postalCode/>
<country>GBR</country>
</addr>
<telecom value="tel:+44-20-1234-1234"/>
<telecom value="mailto:jlorenc@reedtech.com"/>
<contactPerson>
<name>John Lorenc</name>
</contactPerson>
</contactParty>
<assignedEntity>
<assignedOrganization>
<id extension="234567891" root="1.3.6.1.4.1.519.1"/>
<name>Reed Tech Associates</name>
<telecom value="tel:+1-215-441-6454"/>
<telecom value="mailto:gsaner@reedtech.com"/>
</assignedOrganization>
<performance>
<actDefinition>
<code code="C73330" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="UNITED STATES AGENT"/>
</actDefinition>
</performance>
</assignedEntity>
<assignedEntity>
<assignedOrganization>
<id extension="345678912" root="1.3.6.1.4.1.519.1"/>
<name>Reed Tech Imports</name>
<telecom value="tel:+1-215-441-6466"/>
<telecom value="mailto:bmcginty@reedtech.com"/>
</assignedOrganization>
<performance>
<actDefinition>
<code code="C73599" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="IMPORT"/>
</actDefinition>
</performance>
</assignedEntity>
</assignedOrganization>
<performance>
<actDefinition>
<code code="C43360" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="MANUFACTURE"/>
</actDefinition>
</performance>
</assignedEntity>
<assignedEntity>
<assignedOrganization>
<id extension="456789123" root="1.3.6.1.4.1.519.1"/>
<id extension="2345678" root="2.16.840.1.113883.4.82"/>
<name>Reed Tech Pharmaceuticals</name>
<addr>
<streetAddressLine>1 Maple Street</streetAddressLine>
<city>Arlington</city>
<state>VA</state>
<postalCode>22202</postalCode>
<country>USA</country>
</addr>
<contactParty>
<addr>
<streetAddressLine>12 Maple Street</streetAddressLine>
<city>Arlington</city>
<state>VA</state>
<postalCode>22202</postalCode>
<country>USA</country>
</addr>
<telecom value="tel:+1-800-441-6408"/>
<telecom value="mailto:mbayer@reedtech.com"/>
<contactPerson>
<name>Mark Bayer</name>
</contactPerson>
</contactParty>
</assignedOrganization>
<performance>
<actDefinition>
<code code="C43360" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="MANUFACTURE"/>
</actDefinition>
</performance>
</assignedEntity>
<assignedEntity>
<assignedOrganization>
<id extension="567890123" root="1.3.6.1.4.1.519.1"/>
<id extension="3456789" root="2.16.840.1.113883.4.82"/>
<name>GMIN Pharmaceuticals</name>
<addr>
<streetAddressLine>321 Happy Street</streetAddressLine>
<city>Horsham</city>
<state>PA</state>
<postalCode>19044</postalCode>
<country>USA</country>
</addr>
<contactParty>
<addr>
<streetAddressLine>321 Happy Street</streetAddressLine>
<city>Horsham</city>
<state>PA</state>
<postalCode>19044</postalCode>
<country>USA</country>
</addr>
<telecom value="tel:+1-215-555-3434"/>
<telecom value="[[mailto:hjones@gminpharma.com"/|mailto:hjones@gminpharma.com]][[mailto:hjones@gminpharma.com"/|"/]]>
<contactPerson>
<name>Henry Jones</name>
</contactPerson>
</contactParty>
</assignedOrganization>
<performance>
<actDefinition>
<code code="C73607" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="RELABEL"/>
</actDefinition>
</performance>
</assignedEntity>
</assignedOrganization>
</assignedEntity>
</representedOrganization>
</assignedEntity>
</author>
<component>
<nonXMLBody>
<text/>
</nonXMLBody>
</component>
</document>

See also

References